Clean Cells' Webinar - Cytotoxicity testing solutions for ADCC, CDC and apoptosis
Animated by Alexis ROSSIGNOL.
Thursday 1st October 2020 at 4:00 pm.
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Description :
In the field of therapeutic antibodies, standardized and biologically relevant potency assays are required by Regulators for product characterization and quality control. Among the variety of antibody biological activities, the induction of target cell death by either apoptosis, ADCC (antibody-dependent cellular cytotoxicity), CDC (complement-dependent cytotoxicity) or chimeric antigen receptor CAR-T cell therapy is a key mechanism of action, and thus have to be characterized by appropriate potency assays.
To comply to this regulatory requirement, we developed a non radioactive luminescent method, specific of target cell cytolysis. The presentation will focus on the description of this new method for ADCC and CDC measurement, using 3 different antibody models and following an ICH-Q2(R1)- and USP1033-based approach.
Altogether, the results show that this method is a perfect candidate for developing regulatory-compliant potency assays for characterizing cytotoxic biotherapeutics, including antibodies (ADCC, CDC) or cell-based therapies (CAR-T). The high level of sensitivity and the ease of use are also a key advantages at early stages of development.